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Recruiting NCT06068270

Effect of MOPs During Orthodontic Movement in Periodontitis Patients

No phase Interventional Stage IV Periodontitis Orthodontic Tooth Movement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Micro-ostoperforations (MOPs).
Who it may be relevant to
Registry conditions: Stage IV Periodontitis, Orthodontic Tooth Movement. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Randomized Clinical Trial on the Effect of Micro-osteoperforations (MOPs) During Intrusion of Flared Upper Anterior Teeth in Stage IV Periodontitis Patients

Overview

Micro-osteoperforations (MOPs) cause cortical bone injuries and consequently increase the expression of inflammatory mediators, allowing for increased bone and periodontal ligament remodeling associated with orthodontic movement. It remains unclear the effect of orthodontic intrusion combined with MOPs application on teeth with reduced periodontium. The general objective will be to determine the efficacy of MOPs during orthodontic tooth movement (OTM) in terms of periodontal and orthodontic outcomes in stage IV periodontitis patients, case type 2 with pathological tooth migration (PTM), characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component \<5mm)

Detailed description

This is a comparative 2-arm parallel single-blinded randomized controlled clinical trial, with allocation ratio of 1:1, aimed to test an intervention (the use of MOPs) on CAL changes 12 months after placing orthodontic appliances. The control intervention will be the same treatment without the bone traumatic intervention.

Sample: Patients with stage IV periodontitis case type 2 characterized with PTM characterized the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabony component \<5mm) attending the Post-graduate Program of Periodontology and the Post-graduate Program of Orthodontics of the Faculty of Dentistry at the Complutense University of Madrid (UCM).

Interventions

  • Procedure Micro-ostoperforations (MOPs)
    3 MOPs will be performed in the bone next to the root of the experimental tooth. MOPs will be performed using the Excellerator® (Propel Orthodontics, Denstply, Sirona)

Primary outcome measures

  • CAL [Time frame: 12 months]
Secondary outcome measures (12)
  • Type of movement [Time frame: 12 months]
  • Duration of orthodontic treatment [Time frame: >12 months]
  • External apical root resorption (EARR) [Time frame: 12 months]
  • Probing pocket depth (PPD) [Time frame: 12 months]
  • Gingival margin level (GM) [Time frame: 12 months]
  • Gingival recessions [Time frame: 12 months]
  • Bleeding on probing (BOP) [Time frame: 12 months]
  • Suppuration on probing (SOP) [Time frame: 12 months]
  • Plaque index (PI) [Time frame: 12 months]
  • Radiographic periodontal outcomes [Time frame: 12 months]
  • Inflammatory biomarkers in gingival crevicular fluid (GCF) [Time frame: 12 months]
  • Oral health related quality of life questionnaire (OHRQoL) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

Patients will be included if agreeing to undertake combined periodontal and orthodontic therapy following the clinical practice guideline of stage IV periodontitis patients, and fulfilling the following criteria:

  • adult patients older than 18-year-old;
  • systemically healthy (see exclusion criteria);
  • diagnosed as stage IV (Papapanou et al., 2018) case-type 2 (Herrera et al. 2022) periodontitis;
  • the presence of at least one flared tooth of the upper-anterior sextant with an intrabony defect (intrabonny component <5mm) (experimental teeth);
  • in need of orthodontic therapy.

Exclusion criteria

  • systemic diseases (diabetes mellitus, obesity, cardiovascular diseases);
  • any medication that could affect the level of inflammation, (such as chronic antibiotics, phenytoin, cyclosporin, anti-inflammatory drugs, systemic corticosteroids, or calcium channel blockers);
  • pregnant or lactating woman;
  • inability to respond questions or to attend follow-up visits;
  • extreme skeletal malocclusions requiring orthognathic surgery;
  • patients smoking more than 10 cigarettes/day; and
  • the presence of PD greater or equal to 5mm with BOP after step 3 of periodontal therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Faculty of Odontology, University Complutense Madrid — Madrid

Identifiers

NCT: NCT06068270 · URI_113-210923

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗